中医外科外用药剂型特点及剂型创新的思考  

Thinking the characteristics of the surgery of the external use of Chinese medicine formulations and dosage forms of innovation

作　　者：朱朝军[1] 韩炜[2] 吕佳康[2] 吕苑枫 张朝晖[1] 吕祥[4] ZHU Chao- jun1, HAN Wei2, LU Jia - kang2, LU Yuan - feng3, ZHANG Zhao -hui1, LU Xiang4(1. Department of Surgery of Traditional Chinese medicine, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China ; 2. Center for Drug Evaluation, China Food and Drug Administration, Beijing 100022, China; 3. School of Pharmacy, The Chinese University of Hong Kong, Hong Kong; 4. Department of National Drug Clinical Trial Organization, Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200071, Chin)

机构地区：[1]天津中医药大学第二附属医院中医外科,天津300150 [2]国家食品药品监督管理总局药品审评中心,北京100022 [3]香港中文大学药剂学院 [4]上海中医药大学附属市中医医院国家药物临床试验机构,上海200071

出　　处：《中国临床药理学杂志》2018年第14期1728-1731,共4页The Chinese Journal of Clinical Pharmacology

基　　金：天津市卫计委中医中西医结合科研基金资助项目(2015112);天津市中医重点专科专病糖尿病足中医专病基金资助项目

摘　　要：中医外科外用药剂型仍以传统的散剂、丹药、膏药、软膏等为主,部分传统的剂型仍需现用现配,具有用药灵活、疗效可靠的特点,也存在着生物利用度低,药物剂量不宜控制,易污染衣物,黏性小易脱落,易干燥变硬等缺点,不能满足临床需求。传统剂型的缺点和剂型研发的滞后制约了中医外科外用药的临床应用,不能满足临床治疗需求,剂型的创新就显得十分重要。本文阐述了中医外科外用中药剂型的现状,对剂型创新进行了思考。The pharmaceutical dosage form of traditional Chinese medicine（ TCM） surgery are still based on traditional dispersants,dandruid,plaster and ointment. Some of the traditional pharmaceutical dosage form still need to be preparation when it is in need. External use traditional Chinese medicine has the characteristics of drug use flexible,clinical effect is reliable. However,there also exist a lot of shortcomings,such as low bioavailability,drug dose should not be controlled,easily contaminated clothing,viscosity small easy to fall off,dry harden,can not meet the clinical needs. The shortcomings of traditional pharmaceutical dosage form and the lag of dosage forms have restricted the clinical application of external medicine of traditional Chinese medicine surgery. Formulation innovation is very important to meet the needs of clinical treatment. This paper expounds the present situation of traditional Chinese medicine dosage forms,and puts forward the necessity and preliminary thinking of the reform of traditional Chinese medicine dosage form.

关 键 词：外用中药 剂型 中医外科 新药 载体 

分 类 号：R28[医药卫生—中药学]